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. 2022 Jun 3;15:75. doi: 10.1186/s13045-022-01295-3

Table 1.

Current US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals for venetoclax

Indication Regimen
FDA
Treatment of patients with CLL with del(17p) who have been treated with at least one prior therapy [51] Monotherapy
Treatment of patients with CLL who have received at least one prior therapy [32] 2 years fixed duration, combined with rituximab
Treatment of patients with previously untreated CLL [31] 1 year fixed duration, combined with obinutuzumab
Treatment of patients with newly diagnosed AML who are ≥ 75 years old or ineligible for intensive induction due to comorbidities [151, 152] Combined with azacytidine, decitabine or lose-dose cytarabine
EMA
Treatment of patients with CLL with del(17p) or TP53 mutation who are unsuitable for or have failed a B cell receptor pathway inhibitor [51] Monotherapy
Treatment of patients without del(17p) or TP53 mutations who have failed both chemo-immunotherapy and a B cell receptor pathway inhibitor [55, 56] Monotherapy
Treatment of patients with CLL who have received at least one prior therapy [32] 2 years fixed duration, combined with rituximab
Treatment of patients with previously untreated CLL [31] 1 year fixed duration, combined with obinutuzumab
Treatment of patients with newly diagnosed AML who are ineligible for intensive chemotherapy [151] Combined with a hypomethylating agent